The Quality of Reporting Randomised Controlled Trials in the Dermatology Literature in an Era where the CONSORT Statement is a Standard

Abstract

Background

The quality of reporting randomised controlled trials (RCTs) in the dermatology literature has not received much consideration since the late 2000s.

Objectives

We aimed to assess the quality of recently reported RCTs published in dermatology journals, focusing on randomisation processes, blinding, and trial registration.

Methods

We reviewed 2,042 original articles and identified 141 primary reports of RCTs in four dermatology journals (The Journal of the American Academy of Dermatology, JAMA Dermatology, The Journal of Investigative Dermatology, and The British Journal of Dermatology) from January 2015 to December 2017. Details were extracted from articles, supplements, and public trial registries. A multivariable logistic regression analysis was conducted to identify factors associated with optimal reporting quality.

Results

Among the 141 RCTs, 99 (70·2%), 82 (58·2%), and 69 (48·9%) RCTs described methods used for randomisation, allocation concealment, and implementation, respectively. Most trials (n = 126, 89·4%) reported blinding status; however, one‐third did not state similarity of intervention. Furthermore, 52 (36·9%) RCTs were not registered prospectively. Trials published in The British Journal of Dermatology and using central randomisation were significantly associated with optimal reporting quality after adjusting for covariates.

Conclusions

Several critical items in reporting RCTs, including allocation concealment, similarity of interventions in blinded trials, or prospective trial registration have remained unsatisfactory in the recent dermatology literature.

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